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FDA 510(k)

A&I SCOOTER, SC-301

K-Number: K041187 · 2004-05-25

ApplicantWell Success Biotech, Inc.
Decision Date2004-05-25
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

A&I SCOOTER, SC-301 is the device name listed in this FDA 510(k) record. The listed applicant is Well Success Biotech, Inc.. It received FDA 510(k) clearance on 2004-05-25 under 510(k) number K041187. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A&I SCOOTER, SC-301?

A&I SCOOTER, SC-301 is a medical device that received FDA 510(k) clearance on 2004-05-25. The listed applicant is Well Success Biotech, Inc.. The 510(k) number is K041187.

When did A&I SCOOTER, SC-301 receive FDA 510(k) clearance?

A&I SCOOTER, SC-301 received FDA 510(k) clearance on 2004-05-25, under 510(k) number K041187.

Who is the listed applicant for A&I SCOOTER, SC-301?

The FDA 510(k) record lists Well Success Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A&I SCOOTER, SC-301?

The FDA product code for A&I SCOOTER, SC-301 is INI.

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Other records listing Well Success Biotech, Inc. as applicant

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Related Devices (Code: INI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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